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Navigation Bronchoscopy vs CT-Guided Biopsy for Lung Nodules (VERITAS Trial)

N/A

Waitlist Available

Led By Fabien Maldonado, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Location peripheral, here defined as occupying the middle or outer third lung zones.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

VERITAS Trial Summary

This trial will compare which of the two procedures, CT-guided biopsy or navigation bronchoscopy, is better for patients referred for biopsy of a lung nodule.

Who is the study for?

This trial is for patients with a single lung nodule sized between 10 and 30 mm, located in the middle or outer parts of the lungs. They should have an intermediate chance of cancer (10-100%) based on specific prediction models. The nodule must be reachable by both navigation bronchoscopy and CT-guided biopsy as confirmed by experts.Check my eligibility

What is being tested?

The study compares two procedures to biopsy lung nodules: navigation bronchoscopy, which uses airways to reach the growth, and CT-guided biopsy, where a needle goes through the chest wall with CT scan guidance. It aims to find out which method is best for certain lung nodules.See study design

What are the potential side effects?

Potential side effects may include discomfort at the biopsy site, bleeding within the lung (hemoptysis), collapsed lung (pneumothorax), infection risk from invasive procedures, and possible allergic reactions to local anesthesia used during biopsies.

VERITAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My lung cancer is located in the outer or middle part of my lungs.

VERITAS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diagnostic yield

Secondary outcome measures

Bronchoscopy yield

Duration of procedure

Need for F-Nav during navigation bronchoscopy

+12 more

VERITAS Trial Design

2Treatment groups

Experimental Treatment

Group I: Navigation Bronchoscopy (NB) with F-NavExperimental Treatment1 Intervention

Group II: CT-guided BiopsyExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,677 Total Patients Enrolled

MedtronicIndustry Sponsor

606 Previous Clinical Trials

828,409 Total Patients Enrolled

Fabien Maldonado, MD5.02 ReviewsPrincipal Investigator - Vanderbilt-Ingram Cancer Center

Vanderbilt-Ingram Cancer Center

5 Previous Clinical Trials

4,438 Total Patients Enrolled

Media Library

CT-Guided Biopsy Clinical Trial Eligibility Overview. Trial Name: NCT04250194 — N/A

Lung Nodules Research Study Groups: Navigation Bronchoscopy (NB) with F-Nav, CT-guided Biopsy

Lung Nodules Clinical Trial 2023: CT-Guided Biopsy Highlights & Side Effects. Trial Name: NCT04250194 — N/A

CT-Guided Biopsy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04250194 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas is this medical experiment currently operational?

"At the present moment, 7 trial sites are enrolling participants. These include Chicago, Milwaukee and Kansas City as well as another 4 locations. To limit travel requirements during enrolment, we advise you to select a site close to your residence."

Answered by AI

Are there any opportunities for enrollment in this trial currently?

"Indeed, clinicaltrials.gov has evidence that this investigation is actively searching for participants. It was first announced on May 22nd 2020 and the last update took place November 2nd 2022. 258 individuals are required to be recruited across 7 locations."

Answered by AI

What is the current cohort size for this trial?

"To complete this medical investigation, 258 participants that satisfy the eligibility criteria need to be recruited. Patients can sign up for the study at Rush University Medical Center in Chicago or Medical College of Wisconsin in Milwaukee."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration

Fabien Maldonado 2020. "Navigation Endoscopy to Reach Indeterminate Lung Nodules Versus Trans-Thoracic Needle Aspiration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04250194.